Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

Completed · Phase 2

Conditions studied: Insular Thyroid Cancer, Recurrent Thyroid Cancer, Stage II Follicular Thyroid Cancer, Stage II Papillary Thyroid Cancer, Stage IV Follicular Thyroid Cancer, Stage IV Papillary Thyroid Cancer

In brief

This phase II trial is studying how well bortezomib works in treating patients with metastatic thyroid cancer that did not respond to radioactive iodine therapy. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Key facts

Study ID

NCT00104871

Run by

National Cancer Institute (NCI)

People needed

24

Starts

2004-12-01

Expected to finish

2014-04-01

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100%
• Platelet count >= 100,000/mm\^3
• Absolute neutrophil count >= 1,500/mm\^3
• White Blood Count (WBC) >= 3,000/mm\^3
• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =< 2.5 times upper limit of normal
• Bilirubin normal
• No symptomatic congestive heart failure
• Creatinine normal OR creatinine clearance >= 60 mL/min
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other uncontrolled illness
• At least 4 weeks since prior chemotherapy
• No more than 2 prior chemotherapy regimens
• At least 6 months since prior external beam radiotherapy for locoregional disease in the thyroid bed or to the cervical or upper mediastinal lymph nodes (dose =< 6,000 cGy)
• At least 6 months since prior radioiodine therapy
• No prior external radiotherapy to the measured tumor
• Prior thyroidectomy allowed
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents

Where it is running

• University of Colorado at Denver Health Sciences Center — Aurora, Colorado, United States
• Lombardi Comprehensive Cancer Center at Georgetown University — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Dana-Farber Harvard Cancer Center — Boston, Massachusetts, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States
• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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